Thread by @lwoodhouse

This is interesting 👇

https://twitter.com/sarahbeth345/status/1458535577918140419

“In some ways we’re vaccinating children to protect the adults, and it should be the other way around. That if 30 million children already have some form of immunity, they’ve made their contribution to herd immunity already.” —Dr. James Hildreth, FDA advisor

I'm in the process of watching (more or less) this entire 7 hour discussion and here's what comes through clearly: everyone involved is conscious of the fact in approving the vaccine for kids, they're making a risk-benefit analysis. As in there are benefits, and there are risks.

Zealots on both sides will pretend that's not the case, that it's all upside or all downside. The people tasked with assessing and weighing the evidence clearly regard this as a gray area, in which the best they can do is make an informed judgement call. There's no certainty here

“The argument in favor of, ‘this will lead to herd immunity, and reduce transmission': that’s a theoretical possibility; I’ve seen very little data, and in fact most of what I see right now is that regardless of the percentage in terms of vaccination the newer variants seem to...

...be able to pass through the population. So if all we’re focused on is reducing cases in terms of a benefit, I don’t think that’s likely to be realized.” — Dr. Michael Kurilla, NIH

Three times in this discussion, a startling figure is brought up: 42% of kids 5-11 have already been infected with SARS Cov-2. This factors into the advisors' thinking because it suggests that that many kids may already have natural immunity.

NYT threw shade on this figure, but the reporter is Apoorva Mandavilli so take it with a grain of salt. nytimes.com/2021/10/28/hea…

That same NIH scientist, by the way, thinks kids who have already had Covid should get *one* shot *at most.* He's concerned about putting in place a rule with a one-size-fits-all 2-dose rule for every kid.

"We are vaccinating with a prototype spike protein that is no longer circulating, so we have to go to higher and higher levels in order to get sufficient potency in terms of neutralization. Everyone is focused on Delta right now but Delta is on the decline. We can anticipate...

... that the future variants are going to be more distantly related, and simply boosting, which we're likely to need to do in this population in six months if all we're relying on is neutralizing [couldn't make this word out] is going to become harder and harder to do. So I...

...think we need to more carefully evaluate exactly. the vacination schemes that we need going forward, and we simply don't have the data right now to make those decisions." — Dr. Kurilla

Two of the advisors deplore that FDA set it up as a binary vote: yes on approval of the full regimen of the vaxx for all kids 5-11, or no. They think approval should be more surgically crafted, but FDA basically sticks with keeping it an up/down vote (which seems fucked to me.)

Dr. Cody Meissner from Tufts is "torn" because he sympathizes with parents who are desperate to vaxx their kids because they're "so frightened — perhaps overly so," but "the issue is side effects." Notes that 68% of kids hospitalized with Covid have underlying co-morbidities.

That means 32% do not, and if you take 40% of that group "that may have immunity already, we're getting down to a very small percent of otherwise healthy 6-11 year old children who might derive some benefit. And we simply don't know what the side effects will be."

* "are going to be" (sorry)

Notes we don't even know if the vaccine will reduce transmission. Says it is "probably not going to prevent infection," only severe disease. Wants it available to parents as a choice, but worried that approval will lead to vaccine mandates for kids for school...

..."and I do not agree with that." Thinks that would be "an error" until we know more about safety.

By the way there are also plenty of advisors who support approving it with little reservation. I'm highlighting those with the strongest reservations to show the nuance of the calculation, not to pretend it's reflective of a consensus.

Dr. Kurilla further wonders re: kids who have been exposed already (estimated 40% of kids 5-11), "the question really becomes, does this vaccine offer any benefits to them at all?"

Also wonders for kids who have had Delta infection, does giving them a shot of a strain that "goes back almost 2 years" help or hurt their immune response to current variants?

Says the dosing interval is "sub-optimal." Expects they'll need boosters in 6 months, doubts we'll reduce cases, will see breakthroughs and we'll see "all the same problems that Covid does whether or not they're vaccinated."

There seems to be a consensus that everyone wants to give the *option* to parents, especially those of high-risk, immunocompromised kids, to vaccinate. But I didn't hear a word of support for mandating it, and a lot of reservations and outright opposition to doing so.

Kurilla was the only one (out of 18) who didn't vote yes on emergency authorization approval. He abstained.

One advisor who voted yes expressed reservations: pointed out that hospitalization rate in this age group for Covid is 0.1/100,000, or less than 10/million. And risk of myocarditis (for older age group, with different vaccine) was 100-150 cases/million.